Psychedelics to Therapeutics - NYSE American: CYBN NEO: CYBN - April 2022

Page created by Jeremy Blair
 
CONTINUE READING
Psychedelics to Therapeutics - NYSE American: CYBN NEO: CYBN - April 2022
NYSE American: CYBN
                                                        NEO: CYBN

            Psychedelics to
            Therapeutics ™

                                                        April 2022

                                                                 1
November 14, 2021 | WWW.CYBIN.COM
                              WWW.CYBIN.COM
Psychedelics to Therapeutics - NYSE American: CYBN NEO: CYBN - April 2022
Cautionary Statement
The information contained in this presentation has been prepared by Cybin Inc. and its affiliates (“Cybin” or the “Company”). The information contained in this presentation: (a) is provided as at the date hereof, is subject to change without notice, and is based on publicly available information, internally developed data and third
party information from other sources; (b) does not purport to contain all the information that may be necessary or desirable to fully and accurately evaluate an investment in the Company; (c) is not to be considered as a recommendation by the Company that any person make an investment in the Company; and (d) is for
information purposes only and shall not constitute an offer to buy, sell, issue or subscribe for, or the solicitation of an offer to buy, sell or issue, or subscribe for any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Where any opinion or belief is expressed in this presentation, it is based on certain
assumptions and limitations and is an expression of present opinion or belief only. The third-party information has not been independently verified. While the Company may not have verified the third-party information, it believes that it obtained the information from reliable sources and has no reason to believe it is not accurate in
all material respects. No warranties or representations can be made as to the origin, validity, accuracy, completeness, currency or reliability of the information. Cybin disclaims and excludes all liability (to the extent permitted by law), for losses, claims, damages, demands, costs and expenses of whatever nature arising in any way
out of or in connection with the information in this presentation, its accuracy, completeness or by reason of reliance by any person on any of it. This presentation should not be construed as legal, financial or tax advice to any individual, as each individual’s circumstances are different. Readers should consult with their own
professional advisors regarding their particular circumstances. In making an investment decision, investors should not rely solely on the information contained in this presentation. The delivery of this presentation, at any time, will not imply that the information contained in the presentation is correct as of any time subsequent to
the date set forth on the cover page of the presentation or the date at which such information is expressed to be stated, as applicable. No securities commission, exchange or similar regulatory authority in Canada or the United States has reviewed or in any way passed upon the merits of this presentation, and any representation
to the contrary is an offence.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION
Certain statements in this presentation constitute forward-looking information. All statements other than statements of historical fact contained in this presentation, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that
include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. These statements are not historical facts but instead represent only Cybin’s expectations,
estimates and projections regarding future events. These statements are not guaranteeing future performance and involve assumptions, risks and uncertainties that are difficult to predict. Therefore, actual results may differ materially from what is expressed, implied or forecasted in such forward-looking statements.
Forward-looking statements are based on a number of factors and assumptions made by management and considered reasonable at the time such information is provided, and forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or
achievements to be materially different from those expressed or implied by the forward-looking statements. Risk Factors that could cause actual results, performance or achievement to differ materially from those indicated in the forward-looking statements include, but are not limited to the following: regulatory, legislative, legal
or other developments with respect to its operations or business; general economic conditions and financial markets; the loss of key management personnel; capital requirements and liquidity; access to capital; the timing and amount of capital expenditures; the impact of the COVID-19 pandemic; conflicts of interest; uninsurable
risks; and litigation and other factors beyond the Company’s control. Readers are cautioned that the foregoing list and the risk factors under the heading “Risk Factors” are not exhaustive. The forward-looking information and forward-looking statements included in this presentation are made as of the date of this presentation. The
Company does not undertake an obligation to update such forward-looking information or forward-looking information to reflect new information, subsequent events or otherwise unless required by applicable securities law. Readers should not place undue importance on forward-looking information and should not rely upon
this information as of any other date. Third party information has not been independently verified. No warranties or representations can be made as to the origin, validity, accuracy, completeness, currency or reliability of the information.

RISK FACTORS
There are a number of risk factors that could cause future results to differ materially from those described herein. A discussion of the principal risk factors relating to the Company’s operations and business appear in the Company’s most recently filed management's discussion and analysis and the Company's listing statement
dated November 9, 2020, which are available under the Company's profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Additional risks and uncertainties, including those that the Company is not aware of currently, or that it currently deems immaterial, may also adversely
affect the Company’s business or any investment therein. All of the forward-looking statements made in this presentation are qualified by these cautionary statements and other cautionary statements or other factors contained herein. Although management believes that the expectations conveyed by forward-looking
statements herein are reasonable based on information available on the date such forward-looking statements are made, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The Company
undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The forward-looking statements contained herein are presented for the purposes of assisting readers in understanding the Company’s plan,
objectives and goals and may not be appropriate for other purposes. The reader is cautioned not to place undue reliance on forward-looking statements.

CAUTIONARY NOTE REGARDING FUTURE-ORIENTED FINANCIAL INFORMATION
To the extent any forward-looking statement in this presentation constitutes “future-oriented financial information” or “financial outlooks” within the meaning of applicable securities laws, such information is being provided to demonstrate the anticipated market penetration and the reader is cautioned that this information may
not be appropriate for any other purpose and the reader should not place undue reliance on such future-oriented financial information and financial outlooks. Future-oriented financial information and financial outlooks, as with forward-looking statements generally, are, without limitation, based on the assumptions and subject to
the risks set out above under the heading “Cautionary Statement Regarding Forward-Looking Information” The Company’s actual financial position and results of operations may differ materially from management’s current expectations and, as a result, the Company’s revenue and expenses.

CAUTIONARY NOTE REGARDING REGULATORY MATTERS
The Company conducts research and development is focused on developing and commercializing psychedelic-inspired regulated medicines. The Canadian, United States and Ireland federal governments regulate drugs. Psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada), a
Schedule I drug under the Controlled Substances Act and a Schedule I controlled substance in Ireland under the Misuse of Drugs Act, 1977, 1984 and 2015, the Misuse of Drugs Regulations 2017 and the Criminal Justice (Psychoactive Substances) Act 2010. Health Canada, the Food and Drug Administration in the United States and
such similar regulatory authority in Ireland have not approved psilocybin as a drug for any indication. The Company does not deal with psychedelic substances except indirectly within laboratory and clinical trial settings conducted within approved regulatory frameworks in order to identify and develop potential treatments for
medical conditions and, further, does not have any direct or indirect involvement with illegal selling, production or distribution of any substances in jurisdictions in which it operates. No product will be commercialized prior to applicable legal or regulatory approval. For these reasons, the Company may be (a) subject to heightened
scrutiny by regulators, stock exchanges, clearing agencies and other authorities, (b) susceptible to regulatory changes or other changes in law, and (c) subject to risks related to drug development, among other things. There are a number of risks associated with the business of the Company. The Company makes no medical,
treatment or health benefit claims about the Company’s proposed products. Health Canada, the Food and Drug Administration or other similar regulatory authorities have not evaluated claims regarding psilocybin products. The efficacy of such products have not been confirmed by approved research. There is no assurance that
the use of psilocybin can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that the
Company verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.

DRUG DEVELOPMENT
Drug development involves long lead times, is very expensive and involves many variables of uncertainty. Anticipated timelines regarding drug development are based on reasonable assumptions informed by current knowledge and information available to the Company. Every patient treated on future studies can change those
assumptions either positively (to indicate a faster timeline to new drug applications and other approvals) or negatively (to indicate a slower timeline to new drug applications and other approvals). This presentation contains certain forward-looking statements regarding anticipated or possible drug development timelines. Such
statements are informed by, among other things, regulatory guidelines for developing a drug with safety studies, proof of concept studies, and pivotal studies for new drug application submission and approval, and assumes the success of implementation and results of such studies on timelines indicated as possible by such
guidelines, other industry examples, and the Company’s development efforts to date.

INDUSTRY INFORMATION
This presentation also contains or references certain market, industry and peer group data which is based upon information from independent industry publications, market research, analyst reports and surveys and other publicly available sources. Although the Company believes these sources to be generally reliable, such
information is subject to interpretation and cannot be verified with complete certainty due to limits on the availability and reliability of data, the voluntary nature of the data gathering process and other inherent limitations and uncertainties. The Company has not independently verified any of the data from third party sources
referred to in this presentation and accordingly, the accuracy and completeness of such data is not guaranteed.

US DISCLAIMER
This presentation is not an offer of securities for sale in the United States or in any other jurisdiction. Securities may not be offered or sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended.

                                                                                                                                                     WWW.CYBIN.COM                                                                                                                                                                                  2
Psychedelics to Therapeutics - NYSE American: CYBN NEO: CYBN - April 2022
Psychedelics to Therapeutics™
 At Cybin, we are on a mission to engineer transformative
 psychedelic therapeutics to improve patients’ mental health
 and clinical outcomes

 Leveraging decades of human psychedelic research to create
 therapeutics that benefit patients, providers and payers:
    1. Fast onset – less downtime for provider and patient
    2. Short duration – less clinic time and resources needed
    3. Low variability – more predictable responses projected
    4. Lower dosing – efficacy with potential for reduced side effects

                                            WWW.CYBIN.COM                3
Psychedelics to Therapeutics - NYSE American: CYBN NEO: CYBN - April 2022
Strong Leadership Team
Our team has deep-rooted psychedelic, pharmaceutical, regulatory and academic research expertise
with more than 400 years of combined experience in drug development

Corporate

R&D

Clinical

Academic

Advisors

• Successfully helped develop widely used drugs such as: Allegra, Sabril, Anzemet, Vaniqa, Zyprexa, Cymbalta, Neupro & Vimpat
• Overseen 60+ IND programs with FDA
• Worked on the development for the first FDA approved psychedelic compound which is covered by healthcare insurance.

                                                       WWW.CYBIN.COM                                                            4
Psychedelics to Therapeutics - NYSE American: CYBN NEO: CYBN - April 2022
Corporate and Financial Highlights

• Over C$120M raised to date and       • Experienced team that has             Strong Intellectual Property:
  well-funded to progress clinical       previously brought multiple drugs     • Proprietary psychedelic
  trials, M&A and IP strategies          to market                               compounds (new chemical
• Strategic shareholders including     • Grown from 5 to 55 employees            entities)
  long-term U.S. institutional funds     across 4 countries (Canada, U.S.A.,   • Integration with delivery
                                         UK, Ireland)                            platforms
• Cash and equivalents of C$63.6m
  as of December 31, 2021              • Developed 50 novel compounds          • Methods of use in psychiatric
                                         with >10 patent filings across 3        indications
• Covered by 9 research firms and        patent families
  inclusion in 3 psychedelic ETFs                                              • Drug discovery pipeline of
                                       • Completed more than 140                 modified and novel
                                         preclinical studies supporting R&D      tryptamines, phenethylamines
                                         advancement of proprietary              and other compounds of
                                         psychedelic-based molecules             interest

                                                 WWW.CYBIN.COM                                                   5
Psychedelics to Therapeutics - NYSE American: CYBN NEO: CYBN - April 2022
Cybin History and Key Milestones
                                                      Former Pfizer Asia President             Launched the EMBARK™               USPTO grant of ‘318 patent
            Acquired Boston-based
                                                      Theresa Firestone elected to              Psychedelic Facilitator              for deuterated DMT
             Adelia Therapeutics
                                                           Board of Directors                     Training Program                   compound CYB004

                                            R&D Collaboration Agreement                            Cybin lab granted DEA                UK MHRA Scientific
   Founded in 2019
                                               with Greenbrook TMS to                             Schedule I manufacturing             Advisory Meeting for
 by 3 Toronto-based
                                           establish mental health centers                                 license                           CYB003
     co-founders
                                                    of excellence

Dec 2019    Nov 2020    Dec 2020       Jan 2021   Jun 2021     July 2021     Aug 2021 Oct 2021                       Nov 2021     Feb 2022    Mar 2022

                                                                                               Investigational deuterated
               Began trading on                      Former FDA Psychiatry                  psilocybin analog CYB003 shows
           NEO exchange under ticker               Director Dr. Laughren joins              positive preclinical data including            Successful completion
                    ‘CYBN’                          Clinical Advisory Board                       significant advantages                      of CYB003 IND-
                                                                                                    over oral psilocybin                    enabling preclinical
                                                                                                                                                  studies

                                           Kernel Flow partnership, a               Uplisted to NYSE
                                            wearable, quantitative               American, began trading                           The Chopra Foundation
                                           neuroimaging technology                under the ticker 'CYBN'                          Announces Partnership
                                                                                                                                         with Cybin

                                                                        WWW.CYBIN.COM                                                                          6
Psychedelics to Therapeutics - NYSE American: CYBN NEO: CYBN - April 2022
Timeline for Developing Psychedelics to Therapeutics
Q1 2022                Q2 2022                      Q3 2022               Q4 2022

✓ Completed            •   CYB003 IND filing for    •   Initiate CYB003   •   Potential
  CYB003 preclinical       Phase 1/2a MDD trial         Phase 1/2a MDD        CYB003 interim
  studies                                               patient study         data readout
                       ✓ Preclinical data
✓ CYB003 Scientific      announced for              •   Initiate CYB004
  Advice meeting         CYB004 vs DMT                  human pilot
  with UK MHRA                                          study
                       •   Submit CYB004
✓ Initiated EMBARK         regulatory filing for
  Phase 2 IIT study        pilot study

✓ Initiated Kernel     •   Late Q2: preclinical
  Flow feasibility         data expected for
  study                    CYB005

                       •   Nominate CYB005 as
                           partnering candidate

                                               WWW.CYBIN.COM                                   7
Psychedelics to Therapeutics - NYSE American: CYBN NEO: CYBN - April 2022
Unmet Need for Treatment of Mental Health Disorders
                     World Health Organization States That Mental Health Disorders Affect
                                     More Than 900M People Globally (1)
                           Depression                                                           Alcohol Use Disorder                                                                             Anxiety Disorders
                                 CYB003                                                                            CYB003                                                                                       CYB004

                                800,000                                                                            95,000                                                                                 5.1% to 11.9%
 Deaths due to suicide globally every year (1)                                         Estimated alcohol related deaths in the                                                             General anxiety disorder lifetime
                                                                                                                      U.S. (3)                                                           prevalence in the United States (4)

                              Up to 85%                                                                                 3M                                                                                    3% to 7%
      Between 76% and 85% of people in low-
     and middle-income countries receive no                                                Global deaths attributed to alcohol                                                   Social anxiety disorder lifetime prevalence
               treatment for their disorder (1)                                                              consumption (3)                                                                         in the Unites States (4)

The global direct and indirect economic costs from mental disorders is US$2.5 Trillion (2)
(1) https://www.who.int/news-room/fact-sheets/detail/depression   (3) https://www.niaaa.nih.gov/alcohols-effects-health/alcohol-use-disorder & https://www.niaaa.nih.gov/publications/brochures-and-fact-sheets/alcohol-facts-and-statistics
(2) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5007565/         (4) Ruscio et al. Psychol Med. 2008;38(1):15.

                                                                                                         WWW.CYBIN.COM                                                                                                                         8
Psychedelics to Therapeutics - NYSE American: CYBN NEO: CYBN - April 2022
Psychedelics Provide Therapeutic Benefits with Potentially
No Abuse or Addictive Characteristics
Source       J. M. Fish (Ed.),Drugs and Society: U.S. Public Policy,
             pp.149-162, Lanham, MD: Rowman & Littlefield Publishers                                Neuropharmacology. 2018 November ; 142: 143–166.

Study Name   Acute toxicity of drugs versus regulatory status.
             Gable, R. S. (2006)

                                                                                                    Treatment Episode Datasets (TEDS): Rate of Various Drugs as the Primary
Data                                                                                                Substance of Abuse Among Persons 12 Years and Older, 2005–2015
                                                                                                    Primary Substance     2010      2011      2012      2013      2014      2015
                                                                                                    Total (n)         1,932,524 1,936,278 1,834,591 1,762,015 1,639,125 1,537,025
                                                                                                    Hallucinogens (n)     1,791      1,998     2,155      2,177     1,899         1,917
                                                                                                                           0.1%       0.1%      0.1%       0.1%      0.1%         0.1%
                                                                                                    Opiates (n)         443,405    486,729   488,038   507,989    501,680     526,686
                                                                                                                          22.9%      25.1%     26.6%     28.8%      30.6%        34.3%
                                                                                                    Cocaine (n)         158,780    152,349   126,371   106,594     88,623        74,710
                                                                                                                           8.2%       7.9%      6.9%       6.0%      5.4%         4.9%
                                                                                                    Alcohol* (n)        782,764    759,017   709,891   654,808    591,404     521,089
                                                                                                                          40.5%      39.2%     38.7%     37.2%      36.1%        33.9%
                                                                                                    • Alcohol only or with a secondary drug
                                                                                                    Source: (Substance Abuse and Mental Health Services Administration, 2017a)

             Conclusions: Certain drugs have more severe consequences of use than others,           Conclusions: (1) psilocybin has an abuse potential appropriate for CSA scheduling if
Result       can be more addictive, harmful to the body or even lethal. However, legality of a      approved as medicine; (2) psilocybin can provide therapeutic benefits that may
             drug does not consistently predict severity of consequences. Marijuana is illegal in   support the development of an approvable new drug application (NDA) but further
             many locations and yet is considered more innocuous than many other substances         studies are required which this review describes; (3) adverse effects of medical
             (Gable, 2006). Conversely, some of the most harmful drugs, such as opioids, alcohol    psilocybin are manageable when administered according to risk management
             and tobacco are legal and used widely in many countries, including the U.S.A. Figure   approaches; and (4) although further study is required, this review suggests that
             1 displays the most dangerous drugs, based on plotting the dependence potential        placement in Schedule IV may be appropriate if a psilocybin-containing medicine is
             of the drug versus the active/lethal dose.                                             approved.

                                                                           WWW.CYBIN.COM                                                                                                   9
Academic Studies Demonstrate Efficacy of Psychedelic Treatment
JAMAPsychiatry | Original Investigation | November 4, 2020

Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder
A Randomized Clinical Trial
Alan K. Davis, PhD; Frederick S. Barrett, PhD; Darrick G. May, MD; Mary P. Cosimano, MSW; Nathan D. Sepeda, BS; MatthewW. Johnson, PhD;
Patrick H. Finan, PhD; Roland R. Griffiths, PhD

Data:                  17 participants (71%) at week 1 and 17 (71%) at week; 4 had a clinically
                       significant response to the intervention (50% reduction in GRID-HAMD
                       score), and 14 participants (58%) at week 1 and 13 participants (54%) at
                       week 4 were in remission (7 GRID-HAMD score)

Results:               Psilocybin with therapy is efficacious in treating MDD, thus extending
                       the results of previous studies of this intervention in patients with
                       cancer and depression and of a non-randomized study in patients with
                       treatment-resistant depression.                                                                                    *Effect sizes in well-controlled studies in MDD are traditionally very small,
                                                                                                                                          ranging from 0.17 to 0.57

Other
Studies:
                             COMPASS news December 01, 2021

                             Positive results from phase IIb trial of
                             investigational COMP360 psilocybin therapy
                             for treatment-resistant depression

                                                                                                                         WWW.CYBIN.COM                                                                                10
Psychedelic Molecules of Interest
Psychedelic Class        Chemical Structure & Molecule             Primary Target           Predominant Route of Administration
                                                                                            Properties: Psilocybin is typically taken orally and
                                                                                            dephosphorylated to psilocin in the intestinal lining and
                                                                                            liver before entering blood circulation.

 Tryptamine                                                      Serotonin Receptor         Pharmacokinetics: Onset of psychoactive effects begin
                                                                         5-HT2A             within 20-40 minutes after ingestion and last between
                                                                                            2-4 hours depending on dose, species and individual
                                                                                            metabolism. Within 6–8 hours, the subjective drug
                                                                                            effects will have mostly disappeared.

                                                                                            Properties: DMT is not bioavailable when orally ingested
                                                                                            due to rapid elimination by monoamine oxidase A
                                                                                            (MAO-A) in the body. IV or inhalation are the traditional
 Tryptamine                                                      Serotonin Receptor         routes of administration.
                                                                         5-HT2A
                                                                                            Pharmacokinetics: The time course of DMT delivered via
                                                                                            IV is brief. The onset is very rapid, with full effects noted
                                                                                            within 2 minutes and subjective effects usually fully
                                                                                            resolved within 20–30 minutes.

                                                                                            Phenethylamine class: A very large class of molecules
                                                                                            derived from a base benzene ring with an amino group
                                                                 Serotonin Receptors &      attached through two-carbon.
 Phenethylamines                                                 Transport Sites
                                                                                            Derivatives: Includes 2C-B, MDMA, mescaline,
                                                                                            amphetamine analogues such as DOI and DOM, and
                         Phenethylamine
                                                                                            25I-NBOMe.

 In addition to the molecules themselves, there are two important factors in the psychedelic treatment regimen:
    1) Psychological support before, during and after the treatment session
    2) Dosing regimen

                                                            WWW.CYBIN.COM                                                                                   11
Research and Development Pipeline

  PROGRAM1                                                                                                                      DISCOVERY PRECLINICAL PHASE I                                                                            PHASE 2                      PHASE 3                       REGISTRATION

Major Depressive Disorder                                                                                                           Mid-2022: Initiate Phase 1/2a study
CYB003-Deuterated Psilocybin Analog

Alcohol Use Disorder
CYB003-Deuterated Psilocybin Analog

Anxiety Disorders                                                                                                                  Q3 2022: Initiate pilot study
CYB004-Deuterated Dimethyltryptamine (DMT)

Neuroinflammation
CYB005-Phenethylamine Derivative

Mental Distress in Healthcare Workers2                                                                                              Phase 2 IIT study underway
EMBARK–psilocybin for mental distress in frontline healthcare workers

Psychedelic Effects On Brain3                                                                                                       Feasibility study underway
Kernel Flow-Neuroimaging Technology

NOTES:
 1) Subject to receipt of all necessary regulatory approvals from all applicable governmental authorities, including, as applicable, the academic and scientific organizations with which Cybin is working. There are multiple risk factors regarding the ability to successfully commercially scale a chemically synthesized process to
    obtain psilocybin and other analogues.
 2) Phase 2 investigator-initiated study being conducted by Dr. Anthony Back, professor of medicine (oncology) at the UW School of Medicine and co-funded by Cybin.
 3) Cybin-sponsored Phase 1 feasibility study evaluating Kernel’s Flow Technology to measure ketamine’s psychedelic effect on cerebral cortex hemodynamics.

                                                                                                                                                WWW.CYBIN.COM                                                                                                                                                                              12
CYB003: Deuterated Psilocybin Analog
                 Indication: Targeting major depressive
                 disorder (MDD) and alcohol use                    CYB003 Features
                 disorder (AUD) with potential for reduced side
                 effects associated with classical psilocybin         Replaced one or
                                                                      more hydrogen
                 MoA: 5-HT2A-R agonist                                atoms with
                 Current status: IND filing planned for Q2’22;        deuterium, a
                 Phase 1/2a patient trial initiation in mid-2022      heavier stable
                                                                      isotope
                 Completed IND-enabling development:
                                                                     Reduced
                  • Preclinical package demonstrating
                                                                     pharmacokinetic
                    psychedelic activity to support clinical
                                                                     variability
                    development (efficacy and
                    safety)according to FDA guidelines               Improved
                  • Optimized pharmacokinetic (PK) profile           bioavailability

                  • Used to predict efficacious and safe             Development of
                    human doses                                      new chemical
                                                                     entity

                            WWW.CYBIN.COM                                               13
CYB003 provides therapeutic advantages over oral psilocybin
Proprietary molecules, like CYB003, provide improved therapeutic properties over their natural counterparts

                    Properties                      Psilocybin    CYB003         Potential benefits for patients

                Psychedelic effect                      ✓            ✓                  Therapeutic potential

                                                                                 Safer dosing and more predictable
        Low variability in plasma levels                X            ✓                   patient outcomes

               Fast onset of action                                              Less down time in clinic and faster
                                                        X            ✓                   onset of effects
         Short total duration of action                 X            ✓              Shorter clinic days and costs

                                                                                 Therapeutic effects at lower doses,
             Rapid brain distribution                   X            ✓
                                                                                    potentially better tolerability
                                                     Natural     Proprietary

Source: Company data based on preclinical studies

                                                        WWW.CYBIN.COM                                                  14
CYB003 has potential for less variability vs. classic psilocybin

                                  40                                                       180
                                                                                                                                            CYB003

                                  35                                                                                                   Psilocybin
                                                                                           150
 Active Agent Between Subjects

                                                     50%
  Percent Plasma Variability of

                                                                 Plasma Concentration of
                                  30

                                                                   Active Agent (ng/ml)
                                                                                           120
                                  25

                                  20                                                       90

                                  15
                                                                                           60
                                  10
                                                                                           30
                                  5

                                  0                                                        0                                                         *
                                                                                                 0              1    2          3                    4
                                          Psilocybin CYB003         Time (Hours)

                                       Less variability with CYB003 could translate to safer dosing and more predictable patient outcomes

Data is based on plasma concentration profiles following administration of psilocybin or CYB003 to animals

                                                                                                     WWW.CYBIN.COM                                       15
CYB003 may potentially reduce clinic time for patients
by 50% v. classic psilocybin

     Psilocybin                                                                                               Psilocybin

        CYB003                                               50%                                                CYB003                             50%

 Time (Hours) 0             0.2         0.4          0.6         0.8         1                            Time (Hours) 0        1         2         3    4

   CYB003 onset of action is 2X as fast as oral                                                               CYB003 duration effects are cut in half
   psilocybin                                                                                                 compared to oral psilocybin

Data is based on plasma concentration profiles following administration of psilocybin or CYB 003 to animals

                                                                                 WWW.CYBIN.COM                                                               16
CYB003 has potential for less side effects v. classic psilocybin

                                               12
       Brain to Plasma Ratio of Active Agent

                                                                 42%
                                               10

                                               8
                                                                                Improved brain to plasma
                                                                                ratio could result
                                               6                                in therapeutic effects at
                                                                                lower doses and potential
                                               4                                for less side effects

                                               2

                                               0
                                                    Psilocybin         CYB003

Data is based on plasma concentration profiles following administration of psilocybin or CYB 003 to animals

                                                                                WWW.CYBIN.COM                 17
CYB003 Clinical Path to Proof-of-Concept

  Key Features:                                                   The Phase 1/2a trial design allows us to:
  • Randomized, double-blind, placebo-                             • Rapidly escalate into the effective dose
    controlled Phase 1/2a trial design                               range for MDD patients
  • Moderate to severe MDD patients will all                       • Allows for the characterization of the full-
    receive 2 administrations (placebo/active;                       dose response curve
    active/active)                                                 • Provides PK and safety data in a large
  • Response/remission assessed at Week 3                            number of exposures (almost double
    (after single dose) and at Week 6 (after                         normal first-in-human study)
    second dose)                                                   • Evaluate more than one administration to
                                                                     identify greatest efficacy
  • Assess rapid onset of antidepressant effect
    on the day of dosing (using MADRS)                             • Evaluate effect of CYB003 on patients
                                                                     continuing treatment with antidepressant
  • Safety and PK data generation
                                                                     medication

                    Initiation of Phase 1/2a study is expected in mid-2022

                                                  WWW.CYBIN.COM                                                     18
CYB004: Deuterated Dimethyltryptamine (DMT)

                Indication: Targeting anxiety disorders with
                improved control via inhalation                 CYB004 Features
                MoA: 5-HT2A-R agonist
                                                                   Potential to
                Scientific Rationale:                              enhance
                 ✔ DMT has agonistic actions on a range            durability
                    of 5-HT receptors
                 ✔ Efficacy demonstrated in a range of
                                                                   Reduced dose
                    observational and real-world studies in
                                                                   for better safety
                    depression, anxiety and substance use
                    disorders
                                                                   Potential to
                 ✔ Inhalation provides a similar dose profile
                                                                   increase duration
                    as IV DMT and is less invasive
                                                                   of effect
                IP: U.S. patent granted by USPTO
                that covers new chemical entity claims for         Potential to
                CYB004 until 2041                                  alleviate negative
                Current status: Regulatory filing for              experiences
                pilot study anticipated in Q2 2022                 v. DMT

                           WWW.CYBIN.COM                                                19
CYB004 Demonstrates Positive Preclinical Data

             2000%                                                        41%                             300%

        Improved bioavailability                                                                      Longer duration of effect
                                                                     Improved bioavailability
       compared with oral DMT,                                                                    compared with IV DMT, indicating
                                                                  compared with inhaled DMT,
     which is known to have limited                                                                potential to extend therapeutic
                                                                 which may support lower dosing
        to no oral bioavailability                                                                             window

Data is based on preclinical studies of CYB004 in animal model

                                                                        WWW.CYBIN.COM
CYB005: Phenethylamine Derivative - Partnering

                 Indication: Potential to target
                 neuroinflammation in neurological and           CYB005 Features
                 psychiatric conditions
                                                                    Psychoactive
                 MoA: 5-HT2A-R agonist lead candidate               compound that
                                                                    activates CNS
                 Scientific rationale:
                   • Highly potent 5-HT2A agonist                   Long duration of
                                                                    action
                   •   Excellent brain penetration and limited
                       peripheral exposure
                                                                    Favorable
                   •   Induces strong head twitch response
                                                                    in vitro toxicity
                       in vivo
                                                                    data
                   •   Extended duration to allow for
                       infrequent dosing
                                                                    Good oral
                 Development strategy:                              bioavailability
                 Potential partnership opportunity

                            WWW.CYBIN.COM                                               21
Why Cybin?
Our Company:
      ✓ Experienced management team across pharmaceuticals, psychedelics, regulatory,
        and capital markets with proven track record bringing multiple drugs to market
      ✓ Multiple active drug programs targeting mental illness, addiction, neuroinflammation
        and psychiatric disorders
      ✓ Well capitalized to move drug development programs forward

Our Approach:
     ✓ Strong and growing IP portfolio across 3 patent families to support clinical trials,
       M&A, and IP strategies
     ✓ Strong preclinical pipeline of 50+ novel psychedelic-based molecules
     ✓ 50 partnerships with world-class scientists and CROs support R&D programs

Our Future:
     ✓ IND filing for first Phase 1/2a study of deuterated psilocybin analog (CYB003) in Q2’22
     ✓ Pilot study supporting CYB004 program initiating in Q2’22
 Notes:
  ▪ Forward-looking statements are subject to various risks and assumptions. See “Cautionary Notes and Forward-Looking Statements” on page 2 of this presentation.
  ▪ Subject to receipt of all necessary regulatory approvals from all applicable governmental authorities, including, as applicable, the academic and scientific organizations with which Cybin is working. There are multiple risk factors regarding the ability to successfully commercially
    scale a chemically synthesized process to obtain psilocybin and other analogues.
  ▪ Certain statements regarding psilocybin have not been evaluated by the Food and Drug Administration, Health Canada, or other similar regulatory authorities, nor has the efficacy of psilocybin been confirmed by approved research. There is no assurance that any of the
    Company’s compounds will be used to diagnose, treat, cure or prevent any disease or condition and robust scientific research and clinical trials are needed.

                                                                                                                             WWW.CYBIN.COM                                                                                                                                                       22
THANK YOU

                                           NYSE American:CYBN
Contact: ir@cybin.com                                NEO:CYBN

                           WWW.CYBIN.COM                  23
You can also read